Pembrolizumab + Olaparib for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByYuan Yuan, MD PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yuan Yuan

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PARP inhibitor) in advanced BRCA-mutated or Homology-directed repair (HDR)-defect breast cancer.

Eligibility Criteria

This trial is for adults with advanced breast cancer that's linked to a BRCA mutation or HDR-defect. Participants must have measurable disease, adequate organ function, and a life expectancy of at least 16 weeks. Women should be postmenopausal or use two forms of contraception; men must use condoms. Exclusions include recent other treatments, additional cancers needing treatment, inability to take oral meds, certain infections like HIV/Hepatitis B/C, active autoimmune diseases, and known allergies to the drugs tested.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I have a confirmed BRCA mutation or HDR defect.

My breast cancer has a BRCA mutation or HDR defect and is getting worse despite treatment.

I have a tumor that can be measured and hasn't been treated with radiation.

I am postmenopausal or cannot have children and agree to use two effective birth control methods.

I have a preserved tumor sample available for testing.

I am 18 years old or older.

Exclusion Criteria

I am not on steroids or immunosuppressants as of three days ago.

I will not need any cancer treatment other than the trial.

I have another cancer that is getting worse or needs treatment.

I have a history of HIV or active Hepatitis B/C.

I have an autoimmune disease treated with medication in the last 2 years.

I have received an organ or tissue transplant from another person.

I have cancer that has spread to my brain or spinal cord.

I have a lung condition not caused by an infection.

I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

I cannot take pills by mouth and have stomach issues affecting medication absorption.

I have not received a live vaccine in the last 30 days.

I have not had chemotherapy, targeted therapy, or radiation in the last 3 weeks.

I have lasting side effects from cancer treatment, but not hair loss.

I have active tuberculosis.

Participant Groups

The study tests pembrolizumab (an immunotherapy drug) combined with olaparib (a PARP inhibitor) in patients with incurable advanced breast cancer due to BRCA mutations or HDR defects. The main goal is to see how well this combination works by measuring the overall response rate according to specific criteria.

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab + OlaparibExperimental Treatment2 Interventions

This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.

Olaparib is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Lynparza for: